FDA 510(k) Number |
Decision Date |
Device Name |
Applicant |
Contact |
K011512 |
07/09/2001 |
MMODIFICATION TO LAMINARIA |
A & A MEDICAL, INC. |
JIHAD (JAY) MANSOUR |
K003949 |
07/25/2001 |
TACKER, MODEL R65-933 |
A & A MEDICAL, INC. |
JIHAD MANSOUR |
K012013 |
07/13/2001 |
LIFESOURCE MODELS UA-787, UA 787PC, UA-787T |
A & D ENGINEERING, INC. |
JERRY WANG |
K011673 |
07/31/2001 |
ACON AMP ONE STEP AMPHETAMINE TEST STRIP, ACON AMP ONE STEP AMPHETAMINE TEST DEVICE |
ACON LABORATORIES, INC. |
EDWARD TUNG |
K010841 |
07/09/2001 |
ACON COC ONE STEP COCAINE TEST STRIP, ACON COC ONE STEP COCAINE TEST DEVICE |
ACON LABORATORIES, INC. |
ROBERT HUDAK |
K011672 |
07/31/2001 |
ACON MAMP ONE STEP METHAMPHETAMINE TEST STRIP, ACON MAMP ONE STEP METHAMPHETAMINE TEST DEVICE |
ACON LABORATORIES, INC. |
EDWARD TUNG |
K011353 |
07/30/2001 |
ACON OPI ONE STEP OPIATES TEST STRIP, ACON OPI ONE STEP OPIATES TEST DEVICE |
ACON LABORATORIES, INC. |
EDWARD TUNG |
K011189 |
07/16/2001 |
VIADUCT MICROENDOSCOPE AND ACCESSORIES |
ACUEITY, INC. |
MARYBETH FECTEAU |
K011422 |
07/10/2001 |
SURGICAL DRAPES |
ADVANCE MEDICAL DESIGNS, INC. |
BILL GILL |
K012219 |
07/31/2001 |
SCALPFIX CLIP SYSTEM |
AESCULAP, INC. |
LISA M MILLINGTON |
K011824 |
07/02/2001 |
AGILENT M2636B TELEMON B MONITOR (TELEMON B) |
AGILENT TECHNOLOGIES, INC. |
DENISE HALEY |
K012094 |
07/20/2001 |
MODIFICATION TO DEVICE LINK SYSTEM, MODEL M2376A |
AGILENT TECHNOLOGIES, INC. |
MIKE HUDON |
K011078 |
07/13/2001 |
MALLEABLE SHAFT CLAMP |
ALLEGIANCE HEALTHCARE CORP. |
LANCE MARCONI |
K012159 |
07/25/2001 |
RAPID DRUG SCREEN |
AMERICAN BIO MEDICA CORP. |
FRAN WHITE |
K011910 |
07/13/2001 |
IN-FAST BONE SCREW SYSTEM |
AMERICAN MEDICAL SYSTEMS, INC. |
ELSA A LINKE |
K011581 |
07/17/2001 |
AMERITEK BRACHYTHERAPY TEMPLATE |
AMERTEK MEDICAL, INC. |
GREG WIITA |
K010503 |
07/06/2001 |
AMIGO WHEELCHAIR |
AMIGO MOBILITY INTL., INC. |
MIKE LABRAKE |
K002336 |
07/27/2001 |
MS104A, NEWMINI II (EMS-II), MODEL AP-101050T AND MEDTRIM (EMS-V), MODEL AP-102050T |
APEX MEDICAL CORP. |
DANIEL LEE |
K011552 |
07/18/2001 |
UROLOGICAL CATHETER |
APOGEE MEDICAL, INC. |
BRENT D ROBLING |
K010006 |
07/25/2001 |
DRAINAGE CATHETER OR FOLEY CATHETER |
APPLIED MEDICAL RESOURCES CORP. |
ANIL BHALANI |
K011264 |
07/17/2001 |
MESH URETERAL STENT |
APPLIED MEDICAL RESOURCES CORP. |
ANIL BHALANI |
K003779 |
07/12/2001 |
IMMOBILIZATION SYSTEM FOR ENT |
ARPLAY MEDICAL S.A. |
RICHARD BORGI |
K011279 |
07/19/2001 |
ENTEC EVAC PLASMA WAND |
ARTHROCARE CORP. |
BRUCE PROTHRO |
K011808 |
07/10/2001 |
ASIA-MED ACUPUNCTURE NEEDLES, (STANDARD, SPECIAL, COMPACT, APEX) |
ASIA-MED GMBH AND CO KG |
Kevin Walls |
K011834 |
07/10/2001 |
BIS ENGINE |
ASPECT MEDICAL SYSTEMS, INC. |
CHRISTINE M VOZELLA |
K011779 |
07/13/2001 |
AVIDCARE SERIES 100 TELEMANAGEMENT SYSTEM |
AVID CARE CORP. |
JONATHAN S KAHAN |
K011718 |
07/25/2001 |
BAUSCH & LOMB SOFLENS ONE DAY DISPOSABLE (HILAFILCON A) VISIBILITY TINTED CONTACT |
BAUSCH & LOMB, INC. |
DEBRA KETCHUM |
K011199 |
07/02/2001 |
PROVIEW EYE PRESSURE MONITOR |
BAUSCH & LOMB, INC. |
DOUGLAS J FORTUNATO |
K010668 |
07/05/2001 |
BAYER DIAGNOSTICS ADVIA CENTAUR RUBELLA IGM ASSAY |
BAYER CORP. |
William J Pignato |
K011982 |
07/17/2001 |
0.9% SODIUM CHLORIDE INJECTION, USP BD PRE-FILLED FLUSH SYRINGE |
BD |
GREGORY W MORGAN |
K011342 |
07/09/2001 |
COULTER LH 750 HEMATOLOGY ANALYZER, MODEL 6605632 |
BECKMAN COULTER, INC. |
STAN SUGRUE |
K010748 |
07/10/2001 |
SYNCHRON SYSTEMS HEMOGLOBIN A1C REAGENT |
BECKMAN COULTER, INC. |
MARY BETH TANG |
K002099 |
07/09/2001 |
S38 (POLYMACON) SPHERICAL, ASPHERICAL, TORIC AND MULTIFOCAL SOFT CONTACT LENS FOR DAILY WEAR(CLEAR AND TINTED, FULLY- |
BESCON CO., LTD. |
MARTIN DALSING |
K001962 |
07/09/2001 |
S45 (OCUFILCON A) SPHERICAL, ASPHERICAL, TORIC AND MULTIFOCAL SOFT CONTACT LENS FOR DAILY WEAR (CLEAR AND TINTED, FULLY- |
BESCON CO., LTD. |
MARTIN DALSING |
K011853 |
07/17/2001 |
ABBOTT TUMORMARKER-MCC (LYOPHILIZED), LEVELS 1 AND 2, 2ML NO. 6E21-10 |
BIO-RAD |
DONNA CHAPMAN |
K011867 |
07/12/2001 |
LIQUID ASSAYED MULTIQUAL CONTROL LEVEL1 #981600; LEVEL 2 #981700; LEVEL 3 #981800 |
BIO-RAD |
DONNA CHAPMAN |
K003851 |
07/20/2001 |
BIOCHECK HIGH SENSITIVITY C-REACTIVE PROTEIN ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1119 |
BIOCHECK, INC. |
ROBIN J HELLEN |
K003954 |
07/12/2001 |
STIMULAN - CALCIUM SULFATE BONE VOID FILLER KIT |
BIOCOMPOSITES LTD. |
J. STEPHEN BRATT |
K002838 |
07/09/2001 |
GASTRIC SUCTION AND DRAINAGE CATHETER |
BIOENTERICS CORP. |
DAVID MUNJAL |
K011041 |
07/03/2001 |
WATERLASE, MILLENNIUM |
BIOLASE TECHNOLOGY, INC. |
IOANA M RIZOIU |
K011455 |
07/18/2001 |
BIOMET ONCOLOGY SALVAGE SYSTEM (OSS) TAPER STACKING ADAPTER |
BIOMET, INC. |
TRACY J BICKEL |
K012019 |
07/20/2001 |
COLOR BUFFED (CB) DDH FEMORAL STEM |
BIOMET, INC. |
DALENE T BINKLEY |
K011110 |
07/02/2001 |
M2A ACETABULAR SYSTEM |
BIOMET, INC. |
MICHELLE L MCKINLEY |
K011138 |
07/10/2001 |
OXFORD UNICOMPARTMENTAL KNEE FEMORAL COMPONENT |
BIOMET, INC. |
PATRICIA S BERES |
K011522 |
07/31/2001 |
RESORBABLE BONE PINS |
BIOMET, INC. |
MARY L VERSTYNEN |
K011216 |
07/18/2001 |
PVC FREE INTRAVASCULAR ADMINISTRATION SET |
BIOMETRIX LTD. |
MIRIAM ABUTBUL |
K012000 |
07/18/2001 |
1.5MM BONE FIXATION KIT |
BIONX IMPLANTS, LTD. |
TUIJA ANNALA |
K012001 |
07/18/2001 |
SMARTSCREW |
BIONX IMPLANTS, LTD. |
TUIJA ANNALA |
K011525 |
07/16/2001 |
SAFE AT HOME TSH (THYROID STIMULATING HORMONE BLOOD COLLECTION AND TRANSPORT SYSTEM) |
BIOSAFE LABORATORIES, INC. |
LAURIE A WATERS |
K002835 |
07/03/2001 |
BODYSTAT |
BODYSTAT LTD. |
I.J. MEEUWSEN |
K011965 |
07/13/2001 |
IMAGER II UROLOGY TORQUE CATHETER, MODEL 40030X1, 40040X1, AND 40050X1 |
BOSTON SCIENTIFIC CORP. |
ROBERT J MICHALIK |
K003285 |
07/31/2001 |
EXAC TRAC 2.0 (NOVALIS BODY MODULE) |
BRAINLAB, AG |
STEFAN VILSMELIER |
K010734 |
07/30/2001 |
BRANAN MEDICAL CORPERATION MONITECT TCA DRUG SCREEN TEST, MODEL MC21 AND MD21 |
BRANAN MEDICAL CORP. |
RAPHAEL WONG |
K012035 |
07/27/2001 |
BRAUN PRECISION SENSOR PRO, MODEL BP 2590 |
BRAUN GMBH |
FRED SCHLADOR |
K011728 |
07/09/2001 |
BRIGHTWAY BRAND POWDER FREE LATEX EXAMINATION GLOVES, BLUE NON-STERILE, PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS) ( |
BRIGHTWAY HOLDINGS SDN. BHD. |
G. BASKARAN |
K011092 |
07/09/2001 |
CANDELA SPTL-1E PULSED DYE LASER |
CANDELA CORP. |
JOAN CLIFFORD |
K003876 |
07/09/2001 |
US SENSOR #CG-930P; TOCO SENSOR CG-940P |
CARD GUARD SCIENTIFIC SURVIVAL, LTD. |
ALEX GONOROVSKY |
K011797 |
07/03/2001 |
BIOZTECT SENSOR AND BIOZTECT CABLE |
CARDIODYNAMICS INTERNATIONAL CORP. |
BRAIN PARK |
K011689 |
07/25/2001 |
HOMOGENEOUS ENZYMIC HOMOCYSTEINE REAGENT |
CATCH, INC. |
MARK E LEGAZ |
K011419 |
07/16/2001 |
CAVEX COLORCHANGE |
CAVEX HOLLAND B.V. |
RICHARD WOORTMAN |
K011452 |
07/19/2001 |
CAVEX STABISIL |
CAVEX HOLLAND B.V. |
RICHARD WOORTMAN |
K011054 |
07/30/2001 |
RADS |
CHASON HEALTHCARE, LLC. |
CHARLES F NEILSON |
K011243 |
07/06/2001 |
CHATTANOOGA DRY HEAT WHIRLPOOL, MODEL 2000 |
CHATTANOOGA GROUP, INC. |
CHERYL L BAGWELL |
K003438 |
07/03/2001 |
SMART RAD |
CMT MEDICAL TECHNOLOGIES, LTD. |
YESHAYAHU RAZ |
K011481 |
07/02/2001 |
10% PVP; 10% PVP IN EBSS SOLUTION |
CONCEPTION TECHNOLOGIES |
GRACE HOLLAND |
K011573 |
07/02/2001 |
HYALURONIDASE IN HTF MEDIUM; HYALURONIDASE IN EBSS MEDIUM |
CONCEPTION TECHNOLOGIES |
GRACE HOLLAND |
K001780 |
07/31/2001 |
COPAN VIRAL TRANSYSTEM |
COPAN DIAGNOSTICS, INC. |
MARY MCNAMARA-CULLINANE |
K011131 |
07/31/2001 |
METHADONE MICROPLATE EIA URINE APPLICATION |
COZART BIOSCIENCE LTD. |
LESLY MOORE |
K011112 |
07/17/2001 |
CYCLOSPORINE CALIBRATOR |
DADE BEHRING, INC. |
LORRAINE H PIESTRAK |
K011235 |
07/20/2001 |
SYSMEX AUTOMATED COAGULATION ANALYZER / MODEL # CA-1500 |
DADE BEHRING, INC. |
RADAMES RIESGO |
K010871 |
07/09/2001 |
TGL FLEX REAGENT CARTRIDGE |
DADE BEHRING, INC. |
DONNA A WOLF |
K010159 |
07/27/2001 |
DRIED GRAM-NEGATIVE AND GRAM-POSITIVE MIC/COMBO PANELS |
DADE MICROSCAN, INC. |
CYNTHIA VAN DUKER |
K012005 |
07/24/2001 |
MODIFICATION TO ALARMVIEW WIRELESS DATA NETWORK SYSTEM |
DATA CRITICAL CORP. |
TERESA DAVIDSON |
K011999 |
07/24/2001 |
MODIFICATION TO FLEXVIEW CLINICAL MONITORING SYSTEM |
DATA CRITICAL CORP. |
TERESA DAVIDSON |
K011436 |
07/05/2001 |
MOBILE-PATIENT VIEWER |
DATA CRITICAL CORPORATION |
FLORIN TRUUVERT |
K011560 |
07/12/2001 |
TRUBYTE DENTURE BASE RESIN SYSTEM |
DENTSPLY INTL. |
P. JEFFERY LEHN |
K011862 |
07/12/2001 |
DENVER ASCITES SHUNT AND PERCUTANEOUS ACCESS KIT WITH ASCITIES SHUNT |
DENVER BIOMEDICAL, INC. |
BONNIE B VIVIAN |
K010681 |
07/18/2001 |
SUMMIT OCCIPITO-CERVICO-THORACIC (OCT) SPINAL SYSTEM |
DEPUY ACROMED |
FRANK MAAS |
K011099 |
07/06/2001 |
GLOBAL FX POROUS-COATED HUMERAL STEM |
DEPUY ORTHOPAEDICS, INC. |
MARCIA J ARENTZ |
K011489 |
07/31/2001 |
SUMMIT DUOFIX HIP PROSTHESIS |
DEPUY ORTHOPAEDICS, INC. |
MARCIA J ARENTZ |
K011505 |
07/02/2001 |
IMMULITE INTACT PTH, MODEL LKPP1 (100 TESTS), LKPP5 (500 TESTS), IMMULITE 2000 INTACT PTH, MODEL L2KPP (200 TESTS), L2K6 |
DIAGNOSTIC PRODUCTS CORP. |
EDWARD M LEVINE |
K011354 |
07/31/2001 |
HIGH TIBIAL OSTEOTOMY PLATING SYSTEM |
DJ ORTHOPEDICS, LLC |
JAMAL D RUSHDY |
K012024 |
07/25/2001 |
EBI XFIX DFS SYSTEM |
EBI, L.P. |
JON CAPAROTTA |
K012211 |
07/31/2001 |
EFILM WORKSTATION |
EFILM MEDICAL, INC. |
KATHY CHIN |
K012175 |
07/31/2001 |
PASS SPINAL SYSTEM |
ENCORE ORTHOPEDICS, INC. |
JOANNA DROEGE |
K011830 |
07/23/2001 |
TRI-FIX SPINAL FIXATION SYSTEM |
ENDIUS, INC. |
SUSAN FINNERAN |
K011438 |
07/23/2001 |
BILATERAL FITTING OF THE BRANEMARK BONE-ANCHORED HEARING AID (BAHA) SYSTEM. |
ENTIFIC MEDICAL SYSTEMS, INC. |
CONSTANCE BUNDY |
K012031 |
07/26/2001 |
MODIFICATION TO THERMAL ANGEL |
ESTILL MEDICAL TECHNOLOGIES, INC. |
DANIEL T KISTNER |
K011257 |
07/13/2001 |
ENDOPATH NON-BLADED OBTURATOR TROCAR SYSTEM (5 MM) |
ETHICON ENDO-SURGERY, INC. |
KATIE FORDYCE |
K011501 |
07/19/2001 |
ENDOPOUCH RETRIEVER |
ETHICON ENDO-SURGERY, INC. |
DOUG KENTZ |
K011114 |
07/03/2001 |
ETYMOTIC RESEARCH ER-10D OAE PROBE |
ETYMOTIC RESEARCH |
ERIK GUNDERSEN |
K011976 |
07/16/2001 |
OPTETRAK TOTAL KNEE SYSTEM SIZE 0/1 DELTA (LINE EXTENSION) |
EXACTECH, INC. |
GARY J MILLER |
K012251 |
07/31/2001 |
OPTETRAK TOTAL KNEE SYSTEM, STRAIGHT STEM EXTENSIONS - ADDITIONAL SIZES |
EXACTECH, INC. |
ROBERT PAXSON |
K011291 |
07/12/2001 |
TEMPORALSCANNER THERMOMETER, SENSORTOUCH |
EXERGEN CORP. |
WILLIAM HARE |
K011874 |
07/20/2001 |
FADASIS MEDICAL FM-1 NO BLENDER |
FADASIS MEDICAL, INC. |
RAYMOND RIDDLE |
K003855 |
07/03/2001 |
HYALOMATRIX CO |
FIDIA ADVANCED BIOPOLYMERS SRL |
PAOLO RAMPAZZO |
K001508 |
07/25/2001 |
LASERSKIN DRESSING |
FIDIA ADVANCED BIOPOLYMERS SRL |
PAOLO RAMPAZZO |
K011517 |
07/10/2001 |
LUTE; CORE |
FIRST SCIENTIFIC LIMITED |
ADE AKINMADE |
K011520 |
07/23/2001 |
RESTORE-X |
FIRST SCIENTIFIC LIMITED |
ADE AKINMADE |
K010270 |
07/25/2001 |
TREMOROMETER |
FLEXABLE SYSTEMS, INC. |
ROBERT M TRIPP |
K012178 |
07/23/2001 |
FRESENIUS C.A.T.S; ATI AUTOTRANSFUSION SET; PSQ PLASMA SEQUESTRATION SET; PSQ-DD PLASMA SEQUESTRATION DIRECT DRAW |
FRESENIUS HEMOTECHNOLOGY, INC. |
TOM TROTTER |
K011626 |
07/16/2001 |
CONCORD 72 |
GATEWAY ALLOYS, INC. |
JOHN C CONSTANTINE |
K011628 |
07/16/2001 |
CONCORD 82 |
GATEWAY ALLOYS, INC. |
JOHN C CONSTANTINE |
K003831 |
07/20/2001 |
ARTHROSCOPES |
GLOBAL ENDOSCOPY, INC. |
NICK MIRCEA |
K003805 |
07/22/2001 |
GYNECOLOGICAL LAPAROSCOPES |
GLOBAL ENDOSCOPY, INC. |
NICK MIRCEA |
K003802 |
07/22/2001 |
HYSTEROSCOPES |
GLOBAL ENDOSCOPY, INC. |
NICK MIRCEA |
K011786 |
07/12/2001 |
VACUETTE SAFETY BLOOD COLLECTION SET |
GREINER VACUETTE NORTH AMERICA, INC. |
Judi Smith |
K011881 |
07/18/2001 |
DYNALINK .035 BILIARY SELF-EXPANDING STENT SYSTEM |
GUIDANT CORP. |
SABA MODJARRAD |
K012002 |
07/26/2001 |
VIKING OPTIMA GUIDING CATHETER |
GUIDANT CORP. |
STACEY SIMON |
K011669 |
07/09/2001 |
BW ACUPUNCTURE NEEDLES |
H F INTL. CO. |
JOHN N POLITIS |
K011032 |
07/03/2001 |
SMARTJET BONE GRAFT LIQUID APPLICATOR (SPRAY TIP), MODEL SK/S, SMARTJET BONE GRAFT LIQUID APPLICATOR (DUAL LUMEN CANNULA |
HARVEST TECHNOLOGIES, CORP. |
ANNETTE FAGNANT |
K003045 |
07/12/2001 |
HA-TI (HAND TITANIUM SCREW) IMPLANT |
HATI DENTAL AG. |
HEINZ E WICK |
K011130 |
07/05/2001 |
PREMIUM |
HERAEUS KULZER, INC. |
RAPHAEL JUDKINS |
K010541 |
07/31/2001 |
PREVISION CHEM |
HERAEUS KULZER, INC. |
CHERYL V ZIMMERMAN |
K012027 |
07/20/2001 |
MODIFICATION TO XIA SPINE SYSTEM |
HOWMEDICA OSTEONICS |
KAREN ARIEMMA |
K011948 |
07/13/2001 |
HOFFMAN II HYBRID RING CLAMP |
HOWMEDICA OSTEONICS CORP. |
KAREN ARIEMMA |
K012026 |
07/18/2001 |
TRIDENT ALL POLY CUP |
HOWMEDICA OSTEONICS CORP. |
JENNIFER A DAUDELIN |
K012060 |
07/27/2001 |
MODIFICATION TO:HU-FRIEDY BRAND SATIN SWIVEL ULTRASONIC INSERT |
HU-FRIEDY MFG. CO.,INC. |
KEITH DUNN |
K011478 |
07/02/2001 |
I-STAT SYSTEM |
I-STAT CORP. |
PAUL VANDERWERF |
K011155 |
07/12/2001 |
INTERSTRAND 125 & INTERSTRAND 103, MODEL NUMBERS 1251S AND 1031S |
IBT, INC. |
RUTH FEICHT |
K011173 |
07/11/2001 |
TELEPAX |
IMED SYSTEMS & CONSULTING, LLC. |
KENNETH P BONNER |
K011904 |
07/19/2001 |
NEXGEN PRIMARY POROUS PATELLA, MODEL 04-211-IIII-5878-65-ZZ-(STANDARD),04-212-IIII-5878-61-ZZ-(MICRO) |
IMPLEX CORP. |
ROBERT A POGGIE |
K012095 |
07/26/2001 |
THE LPS - CONTINUUM TM HYBRID TIBIA, MODELS 32-5886-2Y-XX (ZIMMER) AND 05-119-XXYY1-0 (IMPLEX) |
IMPLEX CORP. |
ROBERT A POGGIE |
K011914 |
07/27/2001 |
HYDRO2, HS-75 |
INNOVISION, INC. |
DON M WOODFORD |
K011566 |
07/09/2001 |
QUANTA LITE H-TTG (HUMAN TISSUE TRANSGLUTAMINASE) IGA ELISA |
INOVA DIAGNOSTICS, INC. |
BRYS C MYERS |
K011570 |
07/09/2001 |
QUANTA LITE H-TTG (HUMAN TISSUE TRANSGLUTAMINASE) IGG ELISA |
INOVA DIAGNOSTICS, INC. |
BRYS C MYERS |
K011140 |
07/27/2001 |
QUANTA PLEX ENA PROFILE 4 |
INOVA DIAGNOSTICS, INC. |
BRYS C MYERS |
K010599 |
07/02/2001 |
PROTIME MICROCOAGULATION SYSTEM / PROTIME 3 CUVETTE |
INTERNATIONAL TECHNIDYNE CORP. |
JOHN CLAY |
K004003 |
07/19/2001 |
PRO OSTEON 200R WITH CALCIUM SULFATE, MODELS 2RCS038, 2RCS050, 2RCS075, 2RCS10, 2RCS15, 2RCS20, 2RCS225, 2RCS30 |
INTERPORE CROSS INTL. |
LYNN M RODARTI |
K011692 |
07/25/2001 |
HOMOGENEOUS ENZYMIC HOMOCYSTEINE REAGENT |
INTERSECT SYSTEMS, INC. |
MARK LEGAZ |
K011281 |
07/24/2001 |
INTUITIVE SURGICAL ULTRASONIC SHEARS |
INTUITIVE SURGICAL, INC. |
MICHAEL YRAMATEGUI |
K983024 |
07/12/2001 |
PROTON THERAPY SYSTEM |
ION BEAM APPLICATIONS S.A. |
JOHN B REISS |
K011938 |
07/18/2001 |
OIL FOR EMBRYO CULTURE |
IRVINE SCIENTIFIC SALES CO., INC. |
WENDELL LEE |
K011205 |
07/10/2001 |
ISOAID IODINE BRACHTHERAPY SEEDS, MODEL ADVANTAGE I-125 |
ISOAID |
ART WARD |
K011492 |
07/05/2001 |
IN TEN-S |
IVOCLAR NORTH AMERICA, INC. |
ANDERJEET GULATI |
K011596 |
07/17/2001 |
UREA NITROGEN (BUN) LIQUID REAGENT |
JAS DIAGNOSTIC, INC. |
David Johnston |
K011599 |
07/20/2001 |
ALKALINE PHOSPHATASE LIQUID REAGENT |
JAS Diagnostics, Inc. |
David Johnston |
K011900 |
07/31/2001 |
GLUCOSE (HEXOKINASE) |
JAS Diagnostics, Inc. |
David Johnston |
K011441 |
07/09/2001 |
JAS CALCIUM (ARSENAZO) REAGENT |
JAS Diagnostics, Inc. |
David Johnston |
K010546 |
07/10/2001 |
POWDER FREE LATEX EXAMINATION GLOVES |
JB STAR SDN BHD |
Kevin Walls |
K003551 |
07/11/2001 |
VENOUS HARDSHELL CARDIOTOMY RESEVOIR, MODEL VHK 4201 |
JOSTRA AG |
KATHLEEN JOHNSON |
K011780 |
07/25/2001 |
K-ASSAY C1-INA |
KAMIYA BIOMEDICAL CO. |
COLIN GETTY |
K011312 |
07/18/2001 |
BLKS-303 MK MONOPLACE HYPERBARIC SYSTEM |
KHRUNICHEV STATE RESEARCH & PRODUCTION SPACE CENTR |
W T WORKMAN |
K011713 |
07/05/2001 |
SAFESKIN NEON NITRILE - POWDER FREE NEON EXAM GLOVE |
KIMBERLY-CLARK CORP. |
MARCIA JOHNSON |
K990667 |
07/27/2001 |
KLS-MARTIN TEMPORARY CONDYLAR IMPLANT |
KLS-MARTIN L.P. |
ARTHUR J WARD |
K011968 |
07/25/2001 |
STREERABLE PTCA GUIDEWIRE |
LAKE REGION MFG., INC. |
JEFF PUMPER |
K011207 |
07/24/2001 |
LASER PERIPHERALS REUSABLE HOLMIUM FIBER |
LASER PERIPHERALS, LLC. |
NANCY ARNOLD |
K011987 |
07/11/2001 |
MODIFIED M-IV MAMMOGRAPHY SYSTEM |
LORAD, A HOLOGIC CO. |
ROAIDA RIZKALLAH |
K010600 |
07/13/2001 |
SUPREMA POWERED WHEELCHAIR |
LUIGI CHINETTI |
LUIGI CHINETTI |
K010911 |
07/20/2001 |
MACROPORE OS SPINAL SYSTEM |
MACROPORE BIOSURGERY, INC. |
KENNETH K KLEINHENZ |
K002207 |
07/11/2001 |
MACROPOREPX PEDIATRIC SYSTEM |
MACROPORE BIOSURGERY, INC. |
KENNETH K KLEINHENZ |
K011851 |
07/11/2001 |
MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND LNOP SERIES OF SENSORS AND CABLES |
MASIMO CORP. |
JAMES J CRONIN |
K983332 |
07/20/2001 |
NORTHEAST PROTON THERAPY CENTER |
MASSACHUSETTS GENERAL HOSPITAL |
JONATHAN S KAHAN |
K011085 |
07/09/2001 |
GUIDEWIRE INTRODUCER SAFETY NEEDLE |
MEDAMICUS, INC. |
DENNIS S MADISON |
K011740 |
07/02/2001 |
CONTOUR DESIGN GOLD EYELID IMPLANT, MODEL CONTOUR DESIGN (SERIES 3000) |
MEDDEV CORP. |
SUZANNA BRICK |
K011731 |
07/05/2001 |
TRI-POINT LIQUIMMUNE LIQUID ASSAYED CONTROL LEVELS 1,2, AND 3 |
MEDICAL ANALYSIS SYSTEMS, INC. |
DARWIN RICHARDSON |
K012006 |
07/13/2001 |
MEDICAL DEPOT POWER NEB 1 |
MEDICAL DEPOT, INC. |
ART WARD |
K011325 |
07/25/2001 |
MEDIFIX URETEROSCOPE |
MEDIFIX, INC. |
GEORGE ALBULESCU |
K011582 |
07/31/2001 |
QCU ANALYTICAL SOFTWARE PACKAGE |
MEDIS MEDICAL IMAGING SYSTEMS, B.V. |
J.J. HOLLANDER |
K011515 |
07/13/2001 |
MEDLINE GROUNDING PAD |
MEDLINE INDUSTRIES, INC. |
STACEY L BOLEN |
K011998 |
07/26/2001 |
METRONIC SOFAMOR DANEK CEMENT RESTRICTOR |
MEDTRONIC SOFAMOR DANEK, INC. |
RICHARD W TREHARNE |
K011395 |
07/12/2001 |
MEDTRONIC COLVIN-GALLOWAY FUTURE ANNULOPLASTY BAND, MODEL 638B |
MEDTRONIC VASCULAR |
CHARLES DOWD |
K011864 |
07/09/2001 |
TRILLIUM MYOTHERM XP CARDIOPLEGIA DELIVERY SYSTEM, MODELS 41, 41-B |
MEDTRONIC VASCULAR |
MARIE HOLM |
K011254 |
07/10/2001 |
EAR THERMOMETER, MODELS ST613C AND ST613F |
MESURE TECHNOLOGY |
PHIL ZULUETA |
K011955 |
07/16/2001 |
MODIFICATION TO:ACCUSONIC PLUS, MODEL AP-100 |
METRON MEDICAL AUSTRALIA PTY LTD |
ROB HOPKINS |
K003966 |
07/17/2001 |
WUNDCATH CONDUCTION CATHETER |
MICOR, INC. |
JEREMIAH COSTELLO |
K010008 |
07/16/2001 |
AXXESS SPINAL CORD STIMULATION LEAD, MODEL 8000 SERIES, INCLUDING 80XX, 81XX, AND 82XX |
MICRONET MEDICAL, INC. |
CHARLES LEHMAN |
K012028 |
07/27/2001 |
ALLIGER ULTRASONIC SURGICAL SYSTEM MODEL AUSS-5 |
MISONIX, INC. |
ALBERT F CLANCY |
K003254 |
07/09/2001 |
CORTEZ NEEDLE FREE IV CONNECTOR, MODEL MMD-001 |
MISSION MEDICL DEVICES |
DONALD V CANAL |
K011734 |
07/03/2001 |
6-FRENCH, 20-ELECTRODE ELECTROPHYSIOLOGY DIAGNOSTIC CATHETER, MODELS 6U20XXX, 6B20XXX, AND 6F20XXX |
MOGUL ENTERPRISES |
JAMIL MOGUL |
K011117 |
07/09/2001 |
MPS ACACIA MEDFLO INFUSION (LI) AND MPS ACACIA MEDFLO INFUSION (LI) KEEP VEIN OPEN (KVO) ELASTOMERIC PUMPS |
MPS ACACIA |
FERGIE F FERGUSON |
K011360 |
07/19/2001 |
MTP LAPAROMAT DISPOSABLE TUBING SET |
MTP MEDICAL TECHNICAL PROMOTION GMBH |
JAMES A LEE |
K011293 |
07/10/2001 |
POWDER FREE POLYMER COATED LATEX MEDICAL EXAMINATION GLOVES, NON-STERILE W/ PROTEIN CONTENT LABELING CLAIM 50 MCG OR LES |
MULTISAFE SDN BHD |
ABD HADI BIN HUSIN |
K011135 |
07/26/2001 |
GSI AUDERA |
NICOLET BIOMEDICAL |
DAVID W WAGNER |
K011606 |
07/12/2001 |
PURESPERM BUFFER |
NIDACON INTERNATIONAL AB |
DANIEL KAMM |
K011310 |
07/20/2001 |
NIEN MADE NON-INVASIVE BLOOD PRESSURE MONITOR, MODELS HP-BPM0001; HP-BPM0002; HP-BPM0003; HP-BPM0003-1 |
NIEN MADE ELECTRNICS CORP. |
JAMES M DELANEY |
K012194 |
07/20/2001 |
BLOOD PRESSURE MONITOR (SPHYGMOMANOMETER), MODEL HT-110 |
NIHON SEIMITSU SOKKI CO., LTD. |
|
K011557 |
07/12/2001 |
PTA, PTV, ATRIOSEPTOSTOMY, ANGIOGRAPHIC, SIZING CATHETERS |
NUMED, INC. |
NICHELLE R LAFLESH |
K011549 |
07/19/2001 |
OHMEDA MEDICAL SPOT PT LITE PHOTOTHERAPY SYSTEM |
OHMEDA MEDICAL |
ALBERTO F PROFUMO |
K011498 |
07/09/2001 |
EASY CONTROL MICRO INSERTER, MODEL ON385 |
OPHTEC USA, INC. |
RICK MCCARLEY |
K010107 |
07/31/2001 |
R STENT BILIARY ENDOPROSTHESIS |
ORBUS MEDICAL TECHNOLOGIES |
ROBERT FRECHETTE |
K011668 |
07/09/2001 |
VALIDATION OF THE BREATHID SYSTEM, FOR THE DETECTION OF HELICBACTOR PYLORI |
ORIDION MEDICAL 1987 LTD. |
SANDY BROWN |
K010235 |
07/09/2001 |
TEMPTELLER INFRARED EAR THERMOMETER, MODEL CT-30/ CT-30DX |
ORIENTAL SYSTEM TECHNOLOGY, INC. |
SUSAN D GOLDSTEIN-FALK |
K011350 |
07/03/2001 |
STARBAND CRANIAL ORTHOSIS |
ORTHOMERICA PRODUCTS, INC. |
WILLIAM H VON OEHSEN |
K003823 |
07/11/2001 |
SCS DT-02 TRANSVERSE CONNECTOR |
ORTHOTEC, L.L.C. |
PATRICK BERTRANOU |
K010964 |
07/05/2001 |
AUTO-DRIVE LAG SCREW SYSTEM |
OSTEOMED CORP. |
DAWN T HOLDEMAN |
K011118 |
07/20/2001 |
NORMED EXTREMITY TITANIUM HAND AND SMALL FRAGMENT SYSTEM |
OSTEOMEDICS |
ALBERT ENAYATI |
K011052 |
07/30/2001 |
OSTEOMARK NTX POINT OF CARE PRESCRIPTION HOME USE |
OSTEX INTL., INC. |
NANCY JS MALLINAK |
K011997 |
07/10/2001 |
MODULAR VALVE HANDLES FOR ADAPTABLE TUBES, MODEL 1298-XX-XX, 1295-XX-XX |
PAJUNK GMBH |
MARTIN HAUGER |
K012133 |
07/20/2001 |
LIVESURE BARBITURATES SCREEN TEST |
PAN PROBE BIOTECH, INC. |
ALICE H YU |
K012131 |
07/20/2001 |
LIVESURE BENZODIAZEPINES SCREEN TESTS |
PAN PROBE BIOTECH, INC. |
ALICE H YU |
K012107 |
07/20/2001 |
LIVESURE PHENECYCLINE (PCP) SCREEN TESTS |
PAN PROBE BIOTECH, INC. |
ALICE H YU |
K011206 |
07/18/2001 |
PARALLAX BONE AND VERTEBRAL BODY BIOPSY AND INFUSION NEEDLES |
PARALLAX MEDICAL, INC. |
RICHARD M RUEDY |
K011311 |
07/10/2001 |
UROLOGIC |
PCK ELECTRONIC INDUSTRY AND TRADE CO, LTD |
CENGIZ KABAKCI |
K010317 |
07/23/2001 |
AV 800 VENTILATOR |
PENLON LTD. |
ANTHONY PARSONS |
K010318 |
07/23/2001 |
PRIMA OXYGEN MONITOR |
PENLON LTD. |
ANTHONY PARSONS |
K012057 |
07/19/2001 |
CASCADE BATH, MODEL 6900 |
PENNER MANUFACTURING, INC. |
VICKIE J BRADY |
K012061 |
07/19/2001 |
SUPERIOR BATH, MODEL 6300 |
PENNER MANUFACTURING, INC. |
VICKIE BRADY |
K011296 |
07/19/2001 |
INFINION ENHANCEMENT PACKAGE |
PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. |
DUANE PRASCHAN |
K011719 |
07/02/2001 |
PLUS CANCELLOUS BONE SCREWS |
PLUS ORTHOPEDICS |
HARTMUT LOCH, RAC |
K011993 |
07/13/2001 |
QUANTUM BLAST |
PRIDE MOBILITY PRODUCTS CORP. |
GENE R KULON |
K000266 |
07/12/2001 |
PRIMARY CARE SOLUTIONS STERILE SALINE-0.9% SODIUM CHLORIDE FOR DEVICE IRRIGATION |
PRIMARY CARE SOLUTIONS, INC. |
NORMAN RUEDT |
K000265 |
07/12/2001 |
PRIMARY CARE SOLUTIONS STERILE WATER DEVICE IRRIGATION |
PRIMARY CARE SOLUTIONS, INC. |
NORMAN RUEDT |
K011532 |
07/30/2001 |
MITYVAC |
PRISM ENTERPRISES, INC. |
HOWARD M HOLSTEIN |
K011171 |
07/02/2001 |
TAMPAX SCENTED & SATIN SCENTED TAMPAX-JUNIOR, REGULAR, SUPER & SUPER PLUS |
PROCTER & GAMBLE CO. |
MARK M ANDERSON |
K010400 |
07/24/2001 |
VACUUM ASSISTED CORE BIOPSY DEVICE |
PROMEX, INC. |
JOSEPH L MARK |
K011712 |
07/17/2001 |
LATEX EXAMINATION GLOVES- POWDER FREE, BLUE |
PT. SHAMROCK MANUFACTURING CORP. |
EMMY TJOENG |
K011895 |
07/09/2001 |
POWDER-FREE MULTI-PLY LATEX EXAMINATION GLOVES, POLYMER COATED ON OUTSIDE AND NITRILE COATED ON INSIDE, BLUE COLOR WITH |
PWA INDUSTRIES SDN. BHD. |
K. KARUNAKARAN |
K011995 |
07/31/2001 |
POLYMER COATED LATEX MEDICAL EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) |
QUALITY LATEX PRODUCTS MALAYSIA SDN BHD |
SHARENE WAN |
K010337 |
07/25/2001 |
LIPOPRINT SYSTEM, LDL SUBFRACTIONS |
QUANTIMETRIX CORP. |
GEBHARD NEYER |
K011401 |
07/13/2001 |
RAMBLER |
RAMBLER MOBILITY, INC. |
JOEL HUSTED |
K011302 |
07/02/2001 |
RANDOX DIGOXIN |
RANDOX LABORATORIES, LTD. |
PAULINE ARMSTRONG |
K011303 |
07/02/2001 |
RANDOX PHENOBARBITAL |
RANDOX LABORATORIES, LTD. |
PAULINE ARMSTRONG |
K002580 |
07/03/2001 |
PRAIRIE CRUISER |
RAYE'S, INC. |
WILLARD L FRICKEY |
K011345 |
07/20/2001 |
CARDIONAVIGATOR INFORMATION MANAGEMENT SYSTEM |
REYNOLDS MEDICAL LTD. |
GEORGE MYERS |
K011837 |
07/13/2001 |
LIFECARD CF 7 DAY |
REYNOLDS MEDICAL LTD. |
GEORGE MYERS |
K011453 |
07/23/2001 |
TOOTH SHADE RESIN MATERIAL |
RITE-DENT MANUFACTURING CORP. |
CESAR E VELIZ |
K011658 |
07/31/2001 |
CALIBRATOR FOR AUTOMATED SYSTEMS (C.F.A.S.) LIPIDS |
ROCHDIAG |
HELEN T TORNEY |
K011539 |
07/20/2001 |
ROSSMAX MEDIPRO MODEL 100, MODEL 200, AND MODEL 300 BLOOD PRESSURE MONITORS |
ROSSMAX INTERNATIONAL LTD. |
MICHAEL YEH |
K011352 |
07/20/2001 |
ROSSMAX SMARTINFLATE CARDIOPRO, MODEL 1000I AND MODEL 3000I BLOOD PRESSURE MONITORS |
ROSSMAX INTERNATIONAL LTD. |
MICHAEL YEH |
K010522 |
07/31/2001 |
SUREVUE URINE HCG |
SA SCIENTIFIC, INC. |
HARBI A SHADFAN |
K011456 |
07/17/2001 |
DELTA PLUS MULTIACTION SOLUTION FOR RIGID GAS PERMEABLE CONTACT LENSES |
SAUFLON PHARMACEUTICALS, LTD. |
JOHN M SZABOCSIK |
K011924 |
07/10/2001 |
POWDERED BLUE NITRILE EXAMINATION GLOVES |
SELTOM PACIFIC SDN. BHD. |
S SEGARAN |
K011922 |
07/05/2001 |
POWDERED LATEX EXAMINATION GLOVES |
SELTOM PACIFIC SDN. BHD. |
S. SEGARAN |
K011402 |
07/16/2001 |
BIOPSY SITE MARKER |
SENORX, INC. |
AMY BOUCLY |
K012034 |
07/24/2001 |
MODIFICATION TO: SIPAP INFANT NASAL CPAP CIRCUIT |
SENSORMEDICS CORP. |
ALEX STENZLER |
K011883 |
07/17/2001 |
POWDERED SYNTHETIC (YELLOW) VINYL PATIENT EXAMINATION GLOVES |
SHIJIAZHUANG EVERSHARP PLASTIC PRODUCTS CO., LTD. |
JAMES CHU |
K011884 |
07/17/2001 |
POWDERED SYNTHETIC VINYL PATIENT EXAMINATION GLOVES |
SHIJIAZHUANG EVERSHARP PLASTIC PRODUCTS CO., LTD. |
JAMES CHU |
K011882 |
07/10/2001 |
SYNTHETIC POWDER FREE (YELLOW) VINYL PATIENT EXAMINATION GLOVES |
SHIJIAZHUANG EVERSHARP PLASTIC PRODUCTS CO., LTD. |
JAMES CHU |
K011885 |
07/16/2001 |
SYNTHETIC POWDER FREE VINYL PATIENT EXAMINATION GLOVES |
SHIJIAZHUANG EVERSHARP PLASTIC PRODUCTS CO., LTD. |
JAMES CHU |
K011141 |
07/03/2001 |
SHIMADZU WHOLE BODY X-RAY COMPUTED TOMOGRAPHY SCANNER SCT-7800TC |
SHIMADZU CORP. |
MICHAEL FISHBACK |
K012016 |
07/20/2001 |
INFINITY SC 8000 WITH ADVANCED COMMUNICATION OPTION II |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
PENELOPE H GRECO |
K011825 |
07/11/2001 |
RECTOSIGHT RS300-04;AND PROTOSIGHT PS300-04 DEVICE |
SIGHTLINE TECHNOLOGIES LTD. |
SIMCHA EDELL |
K011129 |
07/11/2001 |
SIGN IM NAIL |
SIGN, INC. |
JEANNE DILLNER |
K011925 |
07/12/2001 |
HYPODERMIC NEEDLE-PRO NEEDLE WITH NEEDLE PROTECTION DEVICE; HYPODERMIC NEEDLE-PRO SYRINGE & NEEDLE WITH NEEDLE PROTECTIO |
SIMS PORTEX, INC. |
BRAIN D FARIAS |
K011256 |
07/17/2001 |
TORIC LITE LENS |
SOFLEX CONTACT LENS INDUSTRIES LTD. |
Kevin Walls |
K010415 |
07/23/2001 |
ISODAN |
SPECIALITES SEPTODONT |
PETER S REICHERZ |
K003662 |
07/09/2001 |
SPINE WORKS COLLAR |
SPINE WORKS |
DAN FARLEY |
K011766 |
07/03/2001 |
6F EVALUATOR ELECTROPHYSIOLOGY CATHETER, CRD # 402720,402722; 6F EAVUATOR ELECTROPHYSISOLOGY CATHETER, JSN #402721, 4027 |
ST. JUDE MEDICAL |
ANGELA BYLAND |
K011319 |
07/20/2001 |
STRYKER TITANIUM CROSS-SCREW SYSTEM, MODEL 234-500-1XX |
Stryker Endoscopy |
RYAN YEARSLEY |
K011499 |
07/17/2001 |
VISUALINE AMPHETAMINE DIPSTRIP ASSAY |
SUN BIOMEDICAL LABORATORIES, INC. |
MING SUN |
K011332 |
07/26/2001 |
RF-IVD WIRELESS DOSIMETER-MODEL 1133 |
SUN NUCLEAR CORP. |
WILLIAM E SIMON |
K011229 |
07/11/2001 |
DEVILBISS 9000 SERIES CPAP, MODEL 9001 |
SUNRISE MEDICAL HHG, INC. |
JIM FROEHLICH |
K011170 |
07/05/2001 |
SYNTHES 2.7 MM LC-DCP, 3.5 MM PROFILE |
SYNTHES (USA) |
THOMAS M MAGUIRE |
K011969 |
07/19/2001 |
SYNTHES CERVIFIX SYSTEM |
SYNTHES (USA) |
JONATHAN GILBERT |
K011334 |
07/27/2001 |
SYNTHES CURVED RECONSTRUCTION PLATE |
SYNTHES (USA) |
MATTHEW M HALL |
K011335 |
07/27/2001 |
SYNTHS ONE-THIRD TUBULAR DCL PLATE |
SYNTHES (USA) |
MATTHEW M HULL |
K011947 |
07/02/2001 |
EMIT 2000 VALPROIC ACID ASSAY, MODEL OSR4G229UL |
SYVA CO. |
SUSAN L COLLINS |
K011920 |
07/02/2001 |
EMIT 2000 DIGOXIN ASSAY, MODEL OSR4H229 |
SYVA CO., DADE BEHRING, INC. |
SUSAN L COLLINS |
K011429 |
07/13/2001 |
MODEL 100 ACTIVITY MONITOR |
TELECOM MEDICAL, INC. |
THOMAS C WEHMAN |
K012191 |
07/26/2001 |
TERATECH MODEL 2000 HANDHELD ULTRASOUND SYSTEM WITH DOPPLER AND HARMONIC IMAGING MODES |
TERATECH CORP. |
CHARLES F HOTTINGER |
K011804 |
07/09/2001 |
CAPIOX ARTERIAL FILTER WITH X-COATING, PRODUCT CODE CX*AFO2X |
TERUMO CARDIOVASCULAR SYSTEMS CORP. |
GARRY A COURTNEY |
K011253 |
07/20/2001 |
FLAVORED MALE LATEX CONDOM |
THAI NIPPON RUBBER INDUSTRY CO., LTD. |
ELI J CARTER |
K011663 |
07/30/2001 |
MININEPH A-1 ANTITRYPSIN ANTISERUM, HIGH AND LOW SERUM CONTROLS |
THE BINDING SITE, LTD. |
JAY H GELLER |
K011662 |
07/30/2001 |
MININEPH A-1 TRANSFERRIN ANTISERUM, HIGH AND LOW SERUM CONTROL |
THE BINDING SITE, LTD. |
JAY H GELLER |
K011869 |
07/25/2001 |
XENF-DP RHINO-LARYNGOFIBERSCOPE, ITS ACCESSORIES AND ANCILLARY EQUIPMENT |
THE OLYMPUS OPTICAL CO. |
LAURA STORMS-TYLER |
K004026 |
07/09/2001 |
BRAIDED GUIDING INTRODUCER |
THOMAS MEDICAL PRODUCTS, INC. |
PETER J RAPP |
K004025 |
07/19/2001 |
SPLITTABLE SHEATH INTRODUCER KIT |
THOMAS MEDICAL PRODUCTS, INC. |
KIMBERLY A FISCHER |
K012207 |
07/23/2001 |
ADVANTAGE NASAL MASK, SMALL, ADVANTAGE NASAL MASK. REGULAR, MODELS TMS-2520, TMS 2530 |
TIARA MEDICAL SYSTEMS, INC. |
GEOFFREY SLEEPER |
K011497 |
07/10/2001 |
CYMUN-NBR POWDER FREE BLUE NITRILE EXAMINATION GLOVE |
TILLOTSON HEALTHCARE CORP. |
THOMAS N TILLOTSON |
K003818 |
07/05/2001 |
TITANIUM ABUTMENT HEADS FOR IMZ IMPLANTS |
TITAN IMPLANTS |
LYNETTE L HOWARD |
K011685 |
07/31/2001 |
BISTITE II DC |
TOKUYAMA AMERICA, INC. |
DANIEL J MANELLI |
K011942 |
07/13/2001 |
AEQUALIS PRESS-FIT SHOULDER PROSTHESIS |
TORNIER |
IRENE GOSSET |
K012099 |
07/31/2001 |
MONOCHROME PERFECTLY FLAT PANEL DISPLAYS, ME SERIES |
TOTOKU ELECTRIC CO., LTD |
MIKIO HASEGAWA |
K012097 |
07/12/2001 |
VORTEX |
ULTRAVISUAL MEDICAL SYSTEMS |
GARY J ALLSEBROOK |
K003580 |
07/31/2001 |
UNITIP GASTROINTESTINAL PRESSURE SENSOR CATHETER |
UNISENSOR AG |
ROBERT N CLARK |
K003709 |
07/18/2001 |
SURGICAL DYNAMICS MESH CAGE SYSTEM |
UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC |
JENNIFER E SCHUCK |
K012017 |
07/12/2001 |
VARISEED 7.0 |
VARIAN MEDICAL SYSTEMS |
LINDA S NASH |
K011957 |
07/18/2001 |
IVENT 201 PORTABLE VENTILATOR |
VERSAMED LTD. |
KEN RAICHMAN |
K011787 |
07/06/2001 |
PRECISION TUNA OFFICE SYSTEM WITH NO RECTAL TEMPERATURE MONITORING TAPE |
VIDAMED, INC. |
YI CHEN |
K012171 |
07/24/2001 |
MODIFICATION TO: ARGUS SYSTEM-CONTINUOUS EXPERT CARE NETWORK W/SMART ALRAMS |
VISICU, INC. |
MICHAEL BRESLOW |
K003364 |
07/18/2001 |
VIVO 200 DPS VIVOSCAN |
VIVOSONIC, INC. |
RICHARD KEEN |
K011756 |
07/18/2001 |
ADMIRA FLOW |
VOCO GMBH |
EVAN DICK |
K012072 |
07/12/2001 |
VOXAR VC, MODEL 1.0 |
VOXAR LIMITED |
CONRAD CHIN |
K011076 |
07/16/2001 |
LORENZ STERNAL CLOSURE SYSTEM WITH MODULAR SCREW |
WALTER LORENZ SURGICAL, INC. |
KIM REED |
K002874 |
07/27/2001 |
WELL-TENS |
WELL-LIFE CONSULTANT |
KEVIN CHIU |
K004043 |
07/13/2001 |
METAL TRANSCEND ARTICULATION SYSTEM |
WRIGHT MEDICAL TECHNOLOGY, INC. |
EHAB M ESMAIL |
K011482 |
07/09/2001 |
DERMASAFE CHEMO PLUS POWDER FREE NEOPRENE EXAMINATION GLOVE (TESTED FOR USE WITH CHEMOTHERAPY DRUGS) |
WRP ASIA PACIFIC SDN. BHD. |
YUE WAH CHOW |
K010051 |
07/13/2001 |
POLY-TAPES WITH THE FASTLOK FIXATION DEVICE |
XIROS PLC |
JIM ROWLAND |
K011865 |
07/31/2001 |
ZOLL M SERIES IBP OPERATION; ZOLL M SERIES TEMPERATURE OPTION |
ZOLL MEDICAL CORP. |
PAUL DIAS |
K011847 |
07/13/2001 |
ZYNERGY Z5000 ELECTROPHYSIOLOGY CATHETER WITH Z9000 ACCESSORY CABLE |
ZYNERGY CARDIO VASULAR (ZCV), INC. |
JING ZHANG |